Shapeable porous metal implant

ABSTRACT

Shapeable porous metal implants and methods for use in various procedures are disclosed. The implants can comprise a shell according to some examples. According to one example, the method can include providing a sheet of highly porous metal material having a porosity of between 55% and 90%, and wrapping the sheet of highly porous metal material around at least a first bone of the patient. Further examples can form the sheet intra-operatively to a desired shape. In an example, the porous metal sheet can be formed of tantalum or tantalum alloys.

CLAIM OF PRIORITY

This application is a continuation of U.S. patent application Ser. No.14/845,471, filed on Sep. 4, 2015, which claims the benefit of U.S.Provisional Patent Application Ser. No. 62/049,486, filed on Sep. 12,2014, which applications are incorporated by reference herein in theirentireties.

TECHNICAL FIELD

The present application relates to orthopedic prostheses, and moreparticularly, to an intra-operatively shapeable porous implant andmethods of using the same.

BACKGROUND

Orthopedic procedures are commonly utilized to repair and/or replacedamaged bone and tissue in the human body. Such procedures can utilizeorthopedic implants to replace or augment body components or portions ofbody components that cannot be regenerated or are no longer functioningproperly. Examples of orthopedic implants include spinal implants,dental implants, artificial knees, hips, and ankle joints.

Some orthopedic implants and/or procedures can utilize materials toprovide structural support to an orthopedic implant, to fill a void inbone reconstruction or joint repair, to provide a structure forpermitting ingrowth and attachment of tissue, etc. Such materials can beused to provide structural support to a patient's tissue, such as bonetissue. Among the materials that have been utilized for bone repair orreconstruction is a bone graft, which is known to provide support,promote healing, fill bony cavities, promote fusion and stabilize thesites of fractures.

OVERVIEW

The present inventors recognize, among other things, an opportunity toutilize a thin shapeable porous metal to intra-operatively mold orotherwise be shaped to a patient's anatomy and provide support to boneto aid in bone fusion, bone graft containment, to retain bone fragmentsand/or to direct bone growth, etc. The implant described herein can beused with various procedures to treat injuries such as a long bonefracture, a spinal injury, a maxiofacial injury, etc. In some cases, theimplant described herein can be used to treat anatomy where bone injuryhas not occurred but the risk of a bone injury is present due toosteoporosis and other forms of bone degeneration.

To further illustrate the shapeable porous implant and methods disclosedherein, a non-limiting list of examples is provided here:

In Example 1, a method of supporting bone in a patient, the method canoptionally include providing a sheet of highly porous metal materialhaving a porosity of between 55% and 90% for encouraging bone ingrowthinto said sheet, and wrapping the sheet around at least a first bone ofthe patient.

In Example 2, the method of any one or any combination of Examples 1-11can optionally have the wrapping include shaping the sheetintra-operatively to a desired shape to match an anatomy of the patient.

In Example 3, the method of any one or any combination of Examples 1-11wherein the sheet can optionally have a thickness of between about 0.02inch and about 0.07 inch.

In Example 4, the method of any one or any combination of Examples 1-11wherein the sheet can optionally be introduced as a roll to an operativesite adjacent the first bone.

In Example 5, the method of any one or any combination of Examples 1-11can further optionally include wrapping the sheet around a second bonefor fusing the first bone to the second bone.

In Example 6, the method of any one or any combination of Examples 1-11wherein the wrapping can optionally include shaping the sheet in vivo toan anatomy of the patient.

In Example, 7, the method of any one or any combination of Examples 1-11wherein the method optionally treats one or more of a long bonefracture, a spinal injury, and a maxiofacial injury.

In Example 8, the method of any one or any combination of Examples 1-11can further optionally include disposing the sheet to interface withmultiple sides of the first bone to aid in the retention of bonefragments or to aid in directing bone growth.

In Example 9, the method of any one or any combination of Examples 1-11wherein the sheet can optionally be wrapped fully around the first bone.

In Example 10, the method of any one or any combination of Examples 1-11wherein wrapping the sheet can optionally configure the sheet as a bonegrafting platform.

In Example 11, the method of any one or any combination of Examples 1-11wherein the sheet can optionally have one or more features that areconfigured to facilitate retention of the sheet to the first bone of thepatient.

In Example 12, an orthopedic implant, the implant can optionally includean implantable sheet having a first face opposite a second face, atleast one of the first face and the second face comprising a tissueinterfacing surface, the sheet can be formed of a highly porous metalmaterial having a porosity of between 55% and 90%, wherein the tissueinterface surface can include one or more features configured tofacilitate retention of the sheet to an anatomy of a patient.

In Example 13, the implant of any one or any combination of Examples12-18 wherein the sheet can optionally have a thickness of between about0.02 inch and about 0.07 inch and is configured to allow the sheet to bemolded intra-operatively to a desired shape.

In Example 14, the implant of any one or any combination of Examples12-18 further comprising in combination with a surgical instrumentadapted to receive the sheet as a roll for delivery to the patient.

In Example 15, the implant of any one or any combination of Examples12-18 wherein the porous metal material can optionally comprise atantalum or tantalum alloy.

In Example 16, the implant of any one or any combination of Examples12-18 wherein the sheet can optionally be moldable to at least one bonefor treatment of one or more of a long bone fracture, a spinal injury,and a maxiofacial injury.

In Example 17, the implant of any one or any combination of Examples12-18 wherein the one or more features can optionally comprise a surfacefeature and/or an edge feature.

In Example 18, the implant of any one or any combination of Examples12-18 wherein the one or more features can optionally comprise one ormore of hooks, tabs, barbs, holes, and slots.

In Example 19, a method of fusing at least a first bone to a secondbone, the method can optionally include providing a sheet of highlyporous metal material having a porosity of between 55% and 90%, andpositioning the sheet in contact with the first bone and the second bonefor fusing the first bone to the second bone.

In Example 20, the method of any one or any combination of Examples19-24 further optionally including molding the sheet intra-operativelyto a desired shape.

In Example 21, the method of any one or any combination of Examples19-24 wherein the positioning can optionally include wrapping the sheetaround at least the first bone.

In Example 22, the method of any one or any combination of Examples19-24 wherein the sheet can optionally be wrapped fully around the firstbone.

In Example 23, the method of any one or any combination of Examples19-24 wherein the first bone and the second bone can optionally comprisevertebras of a patient.

In Example 24, the method of any one or any combination of Examples19-24 wherein the first bone and the second bone can optionally be partof a joint in a patient.

In Example 25, the implant or method of any one or any combination ofExamples 1-24 can optionally be configured such that all elements oroptions recited are available to use or select from.

These and other examples and features of the present systems and methodswill be set forth in part in the following Detailed Description. ThisOverview is intended to provide non-limiting examples of the presentsubject matter—it is not intended to provide an exclusive or exhaustiveexplanation. The Detailed Description below is included to providefurther information about the present apparatus, systems and methods.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in the presentdocument.

FIG. 1A is a plan view of a surface of a shapeable porous implantincluding an enlargement of the surface according to an example of thepresent application.

FIG. 1B is a side view of the shapeable porous implant of FIG. 1A.

FIG. 2 is a perspective view of the shapeable porous implant of FIGS. 1Aand 1B, rolled over itself for delivery to a patient.

FIG. 3 is view of a patient's femur having a bone fracture treated by aplurality of shapeable porous implants according to an example of thepresent application.

FIG. 4 is a schematic sectional view of a surgical cannula deliveringthe shapeable porous implant of FIGS. 1A-2 during a posterolateralfusion procedure.

FIG. 5 is a schematic view of a portion of a spine having undergone theposterolateral fusion procedure with shapeable porous implantspositioned in contact with the transverse processes.

FIG. 6 is a schematic view of a portion of a spine having undergone aposterolateral gutter fusion procedure with shapeable porous implantspositioned in contact with a plurality of bone grafts.

DETAILED DESCRIPTION

The present application relates to devices and methods for use invarious procedures such as spinal fusion, long bone fracture,maxiofacial reconstruction, etc. In some instances, the shapeable porousimplant can be shaped intra-operatively to mold with a patient'sanatomy. The shaping of the device can occur in vivo. In furtherexamples, the shapeable porous implant can be configured as a malleablesheet of highly porous material. The sheet can be wrapped to anatomicalstructures and/or defects such as posterior lateral gutters, transverseprocess, bone grafts, fusion across a joint (e.g., arthrodesis), etc. Insome instances, the shapeable porous sheet can have features that aidwith engagement to the patient's anatomy. The porous structure of thesheet promotes bone regrowth and/or ingrowth allowing the device to actas a fusion aid. Additionally or alternatively, the shapeable sheet canbe used to treat a long bone fracture to retain bone fragments and/orhelp direct bone regrowth to a surgical site.

FIGS. 1A and 1B illustrate an exemplary configuration of shapeableporous implant 100. As illustrated in FIGS. 1A and 1B, the shapeableporous implant 100 can comprise a sheet 102 of highly porous metalmaterial having a width w, height h, and thickness t. The porosity ofthe highly porous metal material can be between 55% and 90%. A size anddimensions of the shapeable porous implant can be determined based, inpart, on the size of additional implants (e.g., bone grafts), theporosity of the porous structure utilized, and/or the patient's anatomy,as described below.

In FIG. 1A, the sheet 102 can include one or more features 103, 106disposed along a tissue interfacing surface 104. Edge features 103 suchas slots, tabs, hooks, barbs, holes, etc. can extend from an interiorportion of the sheet 102 toward the edges thereof. Surface feature 106can also comprise slots, tabs, hooks, barbs, holes, etc. and can bedisposed on the interior of the sheet 102. The one or more features 103,106 can be configured to facilitate retention of the porous implant 100to the anatomy of the patient and/or another implant. For example, aslot may receive a portion of a patient's bone or soft tissue.Similarly, a hook or barb can couple to a patient's bone or soft tissue.A hole can be adapted to receive a bone screw, suture, etc.

FIG. 1B illustrates a side view of the sheet 102 showing the tissueinterfacing surface 104 and an example of the surface feature 106. Inthe example of FIG. 1B, the surface feature 106 can comprise a thickenedregion such as a hook. FIG. 1B illustrates that the thickness t of thesheet 102 can have a much smaller dimension than the width w and theheight h. In some examples, the thickness t can be between about 0.02inch to 0.07 inch. This thickness t (among other factors includingporosity) allows the sheet 102 to be molded intra-operatively to adesired shape to wrap an anatomy of the patient as will be furtherdiscussed herein.

In an example, the shapeable porous implant 100 and sheet 102 can beformed of a metal or metal alloy having a porous structure, such as aporous metal described below, to facilitate bone ingrowth or regrowth(e.g., act as a fusion and healing aid).

The enlargement of FIG. 1A illustrates such a porous metal 107. Theporous metal 107 includes a plurality of ligaments 108 defining aplurality of highly interconnected, three-dimensional open spaces orpores 110 therebetween. The porous metal structure can incorporate oneor more of a variety of biocompatible metals. Such structures areparticularly suited for contacting bone and soft tissue, and in thisregard, can be useful as a bone substitute and as cell and tissuereceptive material, for example, by allowing tissue to grow into theporous structure over time to enhance fixation (e.g., osseointegration)between the structure and surrounding bodily structures. According tocertain examples of the present disclosure, an open porous metalstructure may have a porosity as low as 55%, 65%, or 75% or as high as80%, 85%, or 90%, or within any range defined between any pair of theforegoing values. An example of an open porous metal structure isproduced using Trabecular Metal™ Technology available from Zimmer, Inc.,of Warsaw, Ind. Trabecular Metal™ is a trademark of Zimmer, Inc. Such amaterial may be formed from a reticulated vitreous carbon foam substratewhich is infiltrated and coated with a biocompatible metal, such astantalum, by a chemical vapor deposition (“CVD”) process in the mannerdisclosed in detail in U.S. Pat. No. 5,282,861 and in Levine, B. R., etal., “Experimental and Clinical Performance of Porous Tantalum inOrthopedic Surgery”, Biomaterials 27 (2006) 4671-4681, the disclosuresof which are expressly incorporated herein by reference. In addition totantalum, other biocompatible metals may also be used in the formationof a highly porous metal structure such as titanium, a titanium alloy,cobalt chromium, cobalt chromium molybdenum, tantalum, a tantalum alloy,niobium, or alloys of tantalum and niobium with one another or withother metals. It is also within the scope of the present disclosure fora porous metal structure to be in the form of a fiber metal pad or asintered metal layer, such as a Cancellous-Structured Titanium™ (CSTi™)layer. CSTi™ porous layers are manufactured by Zimmer, Inc., of Warsaw,Ind. Cancellous-Structured Titanium™ and CSTi™ are trademarks of Zimmer,Inc.

Generally, a highly porous metal structure will include a largeplurality of metallic ligaments defining open voids (e.g., pores) orchannels therebetween. The open spaces between the ligaments form amatrix of continuous channels having few or no dead ends, such thatgrowth of soft tissue and/or bone through open porous metal issubstantially uninhibited. Thus, the open porous metal may provide alightweight, strong porous structure which is substantially uniform andconsistent in composition, and provides a matrix (e.g., closelyresembling the structure of natural cancellous bone) into which softtissue and bone may grow to provide fixation of the implant tosurrounding bodily structures. According to some aspects of the presentdisclosure, exterior surfaces of an open porous metal structure canfeature terminating ends of the above-described ligaments. Suchterminating ends can be referred to as struts, and they can generate ahigh coefficient of friction along an exposed porous metal surface. Suchfeatures can impart and enhanced affixation ability to an exposed porousmetal surface for adhering to bone and soft tissue. Also, when suchhighly porous metal structures are coupled to an underlying substrate, asmall percentage of the substrate may be in direct contact with theligaments of the highly porous structure, for example, approximately15%, 20%, or 25%, of the surface area of the substrate may be in directcontact with the ligaments of the highly porous structure.

An open porous metal structure may also be fabricated such that itcomprises a variety of densities in order to selectively tailor thestructure for particular orthopedic applications. In particular, asdiscussed in the above-incorporated U.S. Pat. No. 5,282,861, an openporous metal structure may be fabricated to virtually any desireddensity, porosity, and pore size (e.g., pore diameter), and can thus bematched with the surrounding natural tissue in order to provide animproved matrix for tissue ingrowth and mineralization. According tocertain examples, an open porous metal structure may be fabricated tohave a substantially uniform porosity, density, and/or void (pore) sizethroughout, or to comprise at least one of pore size, porosity, and/ordensity being varied within the structure. For example, an open porousmetal structure may have a different pore size and/or porosity atdifferent regions, layers, and surfaces of the structure. The ability toselectively tailor the structural properties of the open porous metal,for example, enables tailoring of the structure for distributing stressloads throughout the surrounding tissue and promoting specific tissueingrown within the open porous metal.

In other examples, an open porous metal structure may comprise an opencell polyurethane foam substrate coated with Ti-6Al-4V alloy using a lowtemperature arc vapor deposition process. Ti-6Al-4V beads may then besintered to the surface of the Ti-6Al-4V-coated polyurethane foamsubstrate. Additionally, another example of an open porous metalstructure may comprise a metal substrate combined with a Ti-6Al-4Vpowder and a ceramic material, which is sintered under heat andpressure. The ceramic particles may thereafter be removed leaving voids,or pores, in the substrate. An open porous metal structure may alsocomprise a Ti-6Al-4V powder which has been suspended in a liquid andinfiltrated and coated on the surface of a polyurethane substrate. TheTi-6Al-4V coating may then be sintered to form a porous metal structuremimicking the polyurethane foam substrate. Further, another example ofan open porous metal structure may comprise a porous metal substratehaving particles, comprising altered geometries, which are sintered to aplurality of outer layers of the metal substrate. Additionally, an openporous metal structure may be fabricated according to electron beammelting (EBM) and/or laser engineered net shaping (LENS). For example,with EBM, metallic layers (comprising one or more of the biomaterials,alloys, and substrates disclosed herein) may be coated (layer by layer)on an open cell substrate using an electron beam in a vacuum. Similarly,with LENS, metallic powder (such as a titanium powder, for example) maybe deposited and coated on an open cell substrate by creating a moltenpool (from a metallic powder) using a focused, high-powered laser beam.

Because the sheet 102 can be formed of a porous structure, like theabove-described porous tantalum, the sheet 102 can promote bone ingrowthand fusion in some circumstances, as described further below.

FIG. 2 illustrates that in some cases the sheet 102 can be shaped as aroll or other shape to better facilitate delivery of the shapeableporous implant 100 to a surgical site. Thus, the thickness of the sheet102 allows the shapeable porous implant 100 to be temporarily deformed(rolled, etc.) to decrease the delivery profile of the sheet.Deformation of the shapeable porous implant 100 prior to and/or duringdelivery can facilitate smaller less invasive access paths to the targetarea allowing for quicker patient recovery among other benefits. Afterdelivery, the sheet 102 can be unrolled or otherwise shaped within thepatient (e.g., reshaped from the delivery shape to an implant shape).

FIG. 3 shows a partial cross section of a patient's anatomy 200including a femur 202 that has sustained a long bone fracture at site204. Examples of shapeable porous implants 100 a, 100 b, and 100 c aredisposed adjacent the site 204 in a target area along the femur 202. Theshapeable porous implants 100 a, 100 b, and 100 c can wrapcircumferentially around the femur 202 (e.g., wrap circumferentiallyaround at least one bone). According to the examples illustrated, theshapeable porous implants 100 a, 100 b, and 100 c can comprise elongatedstrands having circular cross-sections with a diameter of between about0.02 inch to 0.07 inch. Such strands or other elongate elements can haveany suitable cross-sectional shape. The porous implants 100 a, 100 b,and 100 c are disposed to interface with multiple sides of the site toaid in the retention of bone fragments and/or to aid in directing bonegrowth. In FIG. 3, the porous implants 100 a, 100 b, and 100 c can beshaped to provide rings that can surround the site 204 by substantially360° and even overlap with themselves in some instances. Althoughillustrated as cylindrical rings in FIG. 3, the shapeable porousimplants 100 a, 100 b, and 100 c can have various shapes as desired. Forexample, they can be sheets similar to the sheets of FIGS. 1A-2 formedaround the site 204. Although three shapeable porous implants areillustrated spaced apart in FIG. 3, in some cases only a single implantor multiple overlapping implants can be utilized as desired.

FIG. 4 is a cross-sectional view of a portion of a patient's anatomy 300including a posterior view of a portion of the spine surrounded by softtissue 304. In FIG. 4, the patient is undergoing a posterolateral fusionprocedure for which a path 302 has been formed in the soft tissue 304allowing access by a surgical instrument 400 to a site along thetransverse process 301 a.

FIG. 4 illustrates an example where the surgical instrument 400comprises a cannula with a tubular portion 402 and an expandable portion404. Further details regarding the structure and function of the cannulacan be found in co-owned U.S. Pat. Nos. 6,837,891, 7,001,397, 7,033,369,7,108,705, 7,223,278, 7,670,354, 7,674,273, 7,892,171, 7,892,249,7,985,237, 8,317,817, and 8,540,746, which are incorporated herein byreference. The cannula allows access by surgical instruments 406 to thetarget area.

In FIG. 4, the target area can be along the transverse processes 301 aand 301 b of the patient. FIG. 4 illustrates the porous implant 100comprising the sheet 102 positioned in contact with the transverseprocess 301 a but not yet disposed along the transverse process 301 b.The shapeable porous implant 100 can be delivered to the site as a roll(as illustrated in FIG. 2) and then unrolled and wrapped and optionallymolded or otherwise shaped to the transverse process 301 a. In someinstances such as the instance illustrated in FIG. 4, the porous implant100 can be disposed outside the path 302 due to expansion (e.g.unrolling, shaping, molding etc.) of the porous implant 100.

FIG. 5 shows the anatomy 300 including a portion of a spine havingundergone the posterolateral fusion procedure with the shapeable porousimplants 100 comprising sheets positioned in contact with the transverseprocesses 301 a and 301 b and extending to adjacent transverse processesin the anterior/posterior direction. Thus, the shapeable porous implants100 can be positioned in contact with a first bone and a second bone. Infurther instances, the shapeable porous implants 100 can be positionedto facilitate fusion across a joint (e.g. arthrodesis of a joint in atoe, ankle, finger, etc.).

As illustrated in FIG. 5, edge features 103 can aid in connecting theporous implants 100 to bone. Additionally, the porous implants 100 canbe circumferentially wrapped and otherwise shaped to the anatomy (e.g.,the transverse processes 301 a and 301 b). In some circumstances,techniques to secure the porous implants 100 to the anatomy can beutilized including bone cement, fasteners, and surface features (e.g.,hooks, tabs, barbs, holes, slots, etc.). The porous implants 100 can actas a fusion aid to promote bone fusion. In some instances, the porousimplants 100 can act as a bone grafting platform to which one or morebone grafts (FIG. 6) can be anchored. Additionally, the porous implants100 can act as a structure for bone graft containment in somecircumstances.

FIG. 6 illustrates an anatomy 500 comprising a portion of a spine fromthe L4 to S1 having undergone a posterolateral gutter fusion procedure.Shapeable porous implants 100 can be positioned to contact and affix toa plurality of bone grafts 502 and the gutters to the medial and lateralsides. The shapeable porous implants 100 can be molded intra-operativelyto take on a shape that conforms to the gutters. Additionally, theshapeable porous implants 100 can serve as a bone grafting platform towhich the plurality of bone grafts 502 can be attached. The molding ofthe porous implants 100 can take place in vivo and/or ex vivo asdesired. In further instances, the porous implants 100 can act as astructure for bone graft containment and/or as a fusion aid in somecircumstances.

The present application discloses various exemplary methods of treatmentincluding for spinal fusion and long bone fracture. It should beunderstood that the shapeable porous implants can be used in furthertreatments such as maxiofacial reconstruction, arthrodesis of variousjoints, etc. not specifically illustrated. Indeed, the presentapplication contemplates the use of the techniques, devices, systems,and methods disclosed herein for treatments where an injury has notoccurred but the risk of a bone injury is present due to osteoporosisand other forms of bone degeneration. In further examples, the shapeableporous implant(s) can be used with and attached to additionalimplantable devices using known techniques. For example, the porousimplant can be attached to a biocompatible metal such as a titanium ortitanium alloy using known techniques for bonding or attaching. U.S.Pat. No. 7,918,382, entitled “METHOD FOR ATTACHING A POROUS METAL LAYERTO A METAL SUBSTRATE”, directed to a method for attaching a porous metalstructure to a metal substrate for forming orthopedic implants; and U.S.Pat. No. 8,608,049, entitled “METHOD FOR BONDING A TANTALUM STRUCTURE TOA COBALT-ALLOY SUBSTRATE”, directed to a method for bonding a poroustantalum structure to a substrate comprising cobalt or a cobalt-chromiumalloy the disclosures of which are incorporated herein by reference.Reference is also made to U.S. Published Application No. 2012/0125896,entitled “RESISTANCE WELDING A POROUS METAL LAYER TO A METAL SUBSTRATE”,and directed to an apparatus and method for manufacturing an orthopedicprosthesis by resistance welding a porous metal layer to a metalsubstrate of the orthopedic prosthesis.

The present application can include a method of providing support tobone. The method can further include providing a sheet of highly porousmetal material having a porosity of between 55% and 90% for encouragingbone ingrowth into said sheet and wrapping the sheet of highly porousmetal material around at least a first bone of the patient. In furtherexamples, the method can form the porous metal sheet intra-operativelyto a desired shape to match an anatomy of the patient. The method canfurther include providing the sheet with a thickness of between about0.02 inch to 0.07 inch and introducing the sheet to a surgical site as aroll. In a further example, the method wraps around a second bone forfusing the first bone to the second bone. In yet further examples, themethod can treat one or more of a long bone fracture, a spinal injury,and a maxiofacial injury.

The present application can include an orthopedic implant. The implantcan comprise an implantable sheet having a first face opposite a secondface at least one of the first and second face comprising tissueinterfacing surface. The sheet can be formed of a highly porous metalmaterial having a porosity of between 55% and 90%. The tissue interfacesurface can include one or more features configured to facilitateretention of the sheet to an anatomy of a patient. According to afurther example, the sheet can have a thickness of between about 0.02inch to 0.07 inch and is configured to allow the sheet to be moldedintra-operatively to a desired shape to match the anatomy of thepatient. In yet further examples, a surgical instrument can be adaptedto receive the sheet as a roll for delivery to the patient. The porousmetal comprises a tantalum or tantalum alloy. The sheet can be molded toat least one bone for treatment of one or more of a long bone fracture,a spinal injury, and a maxiofacial injury. The one or more features cancomprise one or more of surface features and edge features. The one ormore features can comprise one or more of hooks, tabs, barbs, holes, andslots.

The present application can include a system for treating a patient witha shapeable implant. The system can include a sheet of porous metal anda surgical instrument. The porous metal sheet can have at least onetissue interfacing surface and a thickness of between about 0.02 inch to0.07 inch and is configured to allow the sheet to be moldedintra-operatively to a desired shape to match an anatomy of the patient.The surgical instrument can be configured to deliver the sheet to atarget area within the patient for implantation and molding to thedesired shape.

In an example, the surgical instrument can comprise a cannula adapted toreceive the sheet as a roll. In a further example, the porous metal cancomprise a tantalum or tantalum alloy. In yet a further example, moldingto the desired shape occurs in vivo upon implantation. The sheet can bemolded for treatment of one or more of a long bone fracture, a spinalinjury, and a maxiofacial injury. The sheet can have one or morefeatures that are configured to facilitate retention of the porous metalimplant to the anatomy of the patient.

The present application can additionally include a method of fusing atleast a first bone to a second bone. The method can include providing asheet of highly porous metal material having a porosity of between 55%and 90%, and positioning the sheet in contact with the first bone andthe second bone for fusing the first bone to the second bone of apatient. Further examples of the method can mold the sheetintra-operatively to a desired shape to match an anatomy of the patient.The method can additionally wrap the sheet around at least the firstbone of the patient. Further examples fully surround the site bysubstantially 360° with the wrap. In further examples, the first boneand the second bone can comprise bones of the vertebrae of the patient.Additionally, the method can have the sheet fuse across a joint of thepatient.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention can be practiced. These embodiments are also referred toherein as “examples.” Such examples can include elements in addition tothose shown or described. However, the present inventors alsocontemplate examples in which only those elements shown or described areprovided. Moreover, the present inventors also contemplate examplesusing any combination or permutation of those elements shown ordescribed (or one or more aspects thereof), either with respect to aparticular example (or one or more aspects thereof), or with respect toother examples (or one or more aspects thereof) shown or describedherein.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols. In this document, the terms “a” or “an” are used, as is commonin patent documents, to include one or more than one, independent of anyother instances or usages of “at least one” or “one or more.” In thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated. In this document, the terms “including” and “inwhich” are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, composition, formulation, or process that includes elements inaddition to those listed after such a term in a claim are still deemedto fall within the scope of that claim. Moreover, in the followingclaims, the terms “first,” “second,” and “third,” etc. are used merelyas labels, and are not intended to impose numerical requirements ontheir objects.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. The Abstract is provided to complywith 37 C.F.R. §1.72(b), to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims. Also, in the above Detailed Description,various features may be grouped together to streamline the disclosure.This should not be interpreted as intending that an unclaimed disclosedfeature is essential to any claim. Rather, inventive subject matter maylie in less than all features of a particular disclosed embodiment.Thus, the following claims are hereby incorporated into the DetailedDescription as examples or embodiments, with each claim standing on itsown as a separate embodiment, and it is contemplated that suchembodiments can be combined with each other in various combinations orpermutations. The scope of the invention should be determined withreference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

1. A method of supporting bone in a patient, comprising: providing asheet of highly porous metal material having a porosity of between 55%and 90% for encouraging bone ingrowth into said sheet; and wrapping thesheet around at least a first bone of the patient.
 2. The method ofclaim 1, wherein the wrapping includes shaping the sheetintra-operatively to a desired shape to match an anatomy of the patient.3. The method of claim 1, wherein the sheet has a thickness of betweenabout 0.02 inch and about 0.07 inch.
 4. The method of claim 1, whereinthe sheet is introduced as a roll to an operative site adjacent thefirst bone.
 5. The method of claim 1, further comprising: wrapping thesheet around a second bone for fusing the first bone to the second bone.6. The method of claim 1, wherein the wrapping includes shaping thesheet in vivo to an anatomy of the patient.
 7. The method of claim 1,treats one or more of a long bone fracture, a spinal injury, and amaxiofacial injury.
 8. The method of claim 1, further comprisingdisposing the sheet to interface with multiple sides of the first boneto aid in the retention of bone fragments or to aid in directing bonegrowth.
 9. The method of claim 1, wherein the sheet is wrapped fullyaround the first bone.
 10. The method of claim 1, wherein wrapping thesheet configures the sheet as a bone grafting platform.
 11. The methodof claim 1, wherein the sheet has one or more features that areconfigured to facilitate retention of the sheet to the first bone of thepatient.
 12. The method of claim 1 wherein the sheet has a first faceopposite a second face, at least one of the first face and second facecomprising a tissue interfacing surface.
 13. The method of claim 12further comprising coupling one or more features of the tissueinterfacing surface to the first bone or soft tissue of the patient tofacilitate retention of the sheet to the first bone or soft tissue uponinitial implantation of the sheet into the patient.
 14. The method ofclaim 13 wherein the tissue interfacing surface includes at least one ofa tab, a hook or a barb extending therefrom configured to facilitate theretention of the sheet to the first bone or soft tissue.
 15. A method offusing at least a first bone to a second bone, comprising: providing asheet of highly porous metal material having a porosity of between 55%and 90%; and positioning the sheet in contact with the first bone andthe second bone for fusing the first bone to the second bone.
 16. Themethod of claim 15, further comprising molding the sheetintra-operatively to a desired shape.
 17. A method of supporting bone ina patient, comprising: providing a sheet of highly porous metal materialhaving a porosity of between 55% and 90% for encouraging bone ingrowthinto said sheet; introducing the sheet as a roll to an operative siteadjacent a first bone of a patient; positioning the sheet in contactwith the first bone and a second bone; wrapping the sheet around atleast the first bone.
 18. The method of claim 17, wherein the sheet iswrapped fully around the first bone.
 19. The method of claim 17, whereinthe first bone and the second bone comprise vertebras of the patient.20. The method of claim 17 wherein the first bone and the second boneare part of a joint in the patient.